Vertebral curvature dilation balloon catheter

Abstract

This utility model relates to a vertebral body bending dilation balloon catheter, including an outer tube, a handle assembly, a balloon, and a support wire assembly. The support wire assembly passes through the outer tube and the balloon, with its rear end connected to the handle assembly and its front end heat-fused to the front end of the balloon. The support wire assembly includes a support wire, a spring tube, and a guide tip. The front end of the support wire has a variable diameter section located inside the balloon. The spring tube is sleeved on the variable diameter section, with its rear end welded to the large-diameter end of the variable diameter section. The front end of the spring tube is welded to the guide tip and the small-diameter end of the variable diameter section. The support wire in the balloon section integrates the spring tube structure and the variable diameter design of the support wire, allowing it to work in conjunction with a matching bending endoscopic device during surgery, enabling smoother and faster passage through the lesion area.

Description

Technical Field

[0001] This utility model relates to the field of medical devices, specifically to a vertebral body bending dilation balloon catheter. Background Technology

[0002] For the treatment of osteoporotic vertebral compression fractures, percutaneous curved balloon kyphoplasty (PCKP) can be used clinically. This technique involves inserting a flexible balloon catheter through unilateral puncture, which can create a curved working channel within the vertebral body and achieve bilateral bone cement injection under unilateral puncture conditions, effectively restoring vertebral height and mechanical stability.

[0003] Flexible vertebral dilatation balloon catheters have been gradually applied in clinical practice. These devices often utilize materials such as shape memory alloys to achieve controllable directional bending, allowing for bilateral cavity creation via unilateral puncture, significantly reducing surgical trauma. However, these devices still have certain limitations: shape memory alloys are expensive, leading to higher overall costs and increasing the financial burden on patients, thus hindering their widespread clinical application; furthermore, there is still a risk of catheter entrapment during insertion or removal, which may prolong the procedure and increase operational risks.

[0004] Currently available flexible vertebral dilation balloon catheters typically employ a rigid core tube structure for support within the balloon. However, while the core tube ensures overall balloon support, it hinders the balloon's bending during surgery. This can impede the balloon's smooth and rapid passage into and out of the lesion area, thus prolonging the procedure, damaging surrounding tissues, and increasing the patient's intraoperative risks. Utility Model Content

[0005] The technical problem to be solved by this utility model is to overcome the shortcomings of the prior art and provide a vertebral body bending expansion balloon catheter to solve the technical problem that traditional vertebral body bending expansion balloon catheters cannot pass through the lesion area more smoothly and quickly, thereby prolonging the operation time, damaging surrounding tissues, and increasing the patient's intraoperative risk.

[0006] The technical solution adopted by this utility model to solve its technical problem is:

[0007] A vertebral body flexion dilation balloon catheter is provided, including...

[0008] Outer tube, handle assembly, balloon, and support wire assembly;

[0009] The support wire assembly is inserted into the outer tube and the balloon. The rear end of the support wire assembly is connected to the handle assembly, and the front end of the support wire is heat-fused to the front end of the balloon.

[0010] The support wire assembly includes a support wire, a spring tube, and a guide head. The front end of the support wire is provided with a variable diameter section, the spring tube is sleeved on the variable diameter section, the rear end of the spring tube is welded and fixed to the large diameter end of the variable diameter section, and the front end of the spring tube is welded and fixed to the guide head and the small diameter end of the variable diameter section.

[0011] Furthermore, the support wire and the balloon are joined by hot-melt welding to form a welded block, and the front end face of the welded block forms a guide slope.

[0012] Furthermore, the major diameter of the variable diameter section is 1-1.5 mm, and the minor diameter is 0.2-0.4 mm.

[0013] The length of the variable diameter section is 10-25mm.

[0014] Furthermore, the handle assembly includes a three-way handle and a white nut, the white nut being threadedly connected to the rear end of the three-way handle, and the rear end of the support wire being fixed to the white nut by adhesive application.

[0015] The beneficial effects of this utility model are:

[0016] This novel vertebral body bending dilation balloon catheter eliminates the need for a core tube structure, allowing the use of a larger diameter support wire and significantly enhancing overall support performance. The support wire in the balloon segment integrates a spring tube structure with a variable diameter design, enabling it to work in conjunction with the matching bending aperture device during surgery for smoother and faster passage through the lesion area. This not only helps shorten surgical time and reduce damage to surrounding tissues but also further reduces the risk of postoperative complications.

[0017] The use of the vertebral body bending dilation balloon catheter of this invention avoids the trauma caused by bilateral operation during PCKP surgery, reduces the risk of aggravating vertebral body fracture, bone cement leakage and related neurovascular damage due to multiple punctures, and is conducive to the patient's rapid postoperative recovery. Attached Figure Description

[0018] The present invention will be further described below with reference to the accompanying drawings.

[0019] Figure 1 This is a schematic diagram of the vertebral body bending expansion balloon catheter of this utility model;

[0020] Figure 2 This is a schematic diagram of the front end of the vertebral body bending dilation balloon catheter of this utility model;

[0021] Figure 3 This is a schematic diagram of the support wire;

[0022] Figure 4 This is a schematic diagram of the support wire bending at 90°;

[0023] Figure 5This is a schematic diagram of the support wire bent at 45°;

[0024] Figure 6 This is a schematic diagram of drill cuttings from a curved bone drill inside a vertebra;

[0025] Figure 7 This is a schematic diagram of the vertebral body bending dilation balloon catheter expanding within the vertebral body to form a cavity;

[0026] Among them, 1. outer tube, 2. handle assembly, 21. tee handle, 22. white nut, 3. balloon, 31. welding block, 4. support wire assembly, 41. support wire, 411. reducing section, 42. spring tube, 43. guide head;

[0027] 5. Working sleeve; 6. Bending cavity opener. Detailed Implementation

[0028] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.

[0029] This application provides a vertebral body bending dilation balloon catheter, which will be described in detail below. It should be noted that the order of description of the following embodiments is not intended to limit the preferred order of the embodiments of this application. Furthermore, the descriptions of each embodiment have their own emphasis; parts not described in detail in a certain embodiment can be referred to in the relevant descriptions of other embodiments.

[0030] To address the technical problem in existing technologies where traditional vertebral body bending expansion balloon catheters are unsuitable for bending the balloon 3 during surgery, thus preventing coordinated operation with the matching bending aperture 6 and hindering smooth and rapid passage through the lesion area, thereby prolonging operation time, damaging surrounding tissues, and increasing intraoperative risks for patients, an embodiment of this application provides a vertebral body bending expansion balloon catheter. This is described in detail below.

[0031] like Figures 1 to 3 As shown, a vertebral body tortuosity dilation balloon catheter includes...

[0032] 1. Outer tube; 2. Handle assembly; 3. Balloon; and 4. Support wire assembly;

[0033] The support wire assembly 4 is inserted into the outer tube 1 and the balloon 3. The rear end of the support wire assembly 4 is connected to the handle assembly 2, and the front end of the support wire 41 is heat-fused to the front end of the balloon 3.

[0034] like Figure 2 and Figure 3 As shown, the support wire assembly 4 includes a support wire 41, a spring tube 42, and a guide head 43. The front end of the support wire 41 is provided with a variable diameter section 411. The spring tube 42 is sleeved on the variable diameter section 411. The rear end of the spring tube 42 is welded and fixed to the large diameter end of the variable diameter section 411. The front end of the spring tube 42 is welded and fixed to the guide head 43 and the small diameter end of the variable diameter section 411.

[0035] The variable diameter section 411 ensures that the balloon 3 can be easily bent, and the spring tube 42 is welded to both ends of the variable diameter section 411 to provide axial support for the variable diameter section 411.

[0036] The variable diameter section 411, the support wire 41, and the guide head 43 are an integral structure.

[0037] Specifically, as an optional implementation method in this embodiment, such as Figure 2 As shown, the support wire 41 and the balloon 3 are formed by hot-melt welding to form a welding block 31, and the front end face of the welding block 31 forms a guide slope.

[0038] In this embodiment, the major diameter of the variable diameter section is 1-1.5 mm, and the minor diameter is 0.2-0.4 mm.

[0039] The length of the variable diameter section is 10-25mm.

[0040] In one embodiment, the major diameter of the variable diameter section 411 is preferably 1.2 mm, and the minor diameter is preferably 0.3 mm.

[0041] The length of the variable diameter section 411 is preferably 20 mm. Correspondingly, the size of the balloon 3 is also around 20 mm.

[0042] Specifically, as an optional implementation method in this embodiment, such as Figure 1 and Figure 3 As shown, the handle assembly 2 includes a three-way handle 21 and a white nut 22. The white nut 22 is threadedly connected to the rear end of the three-way handle 21, and the rear end of the support wire 41 is fixed to the white nut 22 by adhesive dotting.

[0043] In this embodiment, the outer tube 1 is a single-lumen tube, and its rear end is glued to the three-way handle 21 and communicates with the injection chamber of the three-way handle 21. The outer tube 1 and the three-way handle 21 are connected by a protective sleeve.

[0044] like Figure 4 As shown, the support wire is bent at 90°;

[0045] like Figure 5 As shown, the support wire is bent at 45°.

[0046] The fabrication process of a vertebral body curvature dilation balloon catheter:

[0047] Weld the variable diameter section 411 of the support wire 41 to the spring tube 42, then glue the rear end of the support wire 41 to the white nut 22. Next, insert the support wire 41 into the guide wire cavity of the three-way handle 21, and perform heat fusion welding between the guide head 43 at the front end of the support wire 41 and the distal end of the balloon 3. After welding, use a special tool to cut the bevel. The white nut 22 and the three-way handle 21 are also sealed with glue.

[0048] Advantages of this novel vertebral body bending expansion balloon catheter:

[0049] 1. The guide bevel design at the tip of the balloon catheter allows it to flexibly follow the channel established by the curved opening device 6 during the operation, smoothly reach the lesion area, and achieve precise positioning and operation.

[0050] 2. The design of the variable diameter section 411 on the support wire 41 makes the balloon 3 easy to bend, and its maximum bending arc and overall length can meet the puncture requirements of human thoracic vertebrae, lumbar vertebrae and other segments. When establishing a working channel in the vertebral body, the operator can flexibly adjust the catheter insertion depth according to the location of the lesion to adapt to different bending states and accurately reach the target area.

[0051] 3. The support wire 41 utilizes the synergistic effect of the spring tube 42 and the variable diameter section 411 to ensure smoother passage of the catheter through the lesion during both insertion and retraction. Under unloaded conditions, the catheter automatically returns to a straight shape; however, when the distal bevel encounters resistance, it triggers directional bending. This feature ensures that the catheter can be smoothly withdrawn along its original path after the procedure, reducing the risk of tissue damage.

[0052] The surgical procedure is as follows:

[0053] 1. After the puncture is completed, remove the inner core of the puncture needle and leave the working cannula 5 along the puncture needle sheath, thus establishing a stable working channel to the vertebral body.

[0054] 2. After confirming the location and shape of the lesion in the vertebral body by X-ray, set the bending direction of the front end of the endoscopic device, straighten it, and insert it into the vertebral body through the working sleeve 5.

[0055] 3. Under continuous X-ray monitoring, the surgeon first gently taps the tail of the endoscopic device with a surgical hammer, then steadily advances its front end to accurately reach the lesion target.

[0056] 4. For example Figure 6 As shown, the curved endoscopic device 6, with its pre-bent design and distal bevel, can follow the cancellous bone structure. The surgeon can adjust the advancement depth according to bone density, forming a curved tunnel within the vertebral body leading to the lesion, thus preparing a channel for subsequent balloon dilation 3. After the operation is completed, the endoscopic device is withdrawn, leaving the working cannula 5 in place.

[0057] 5. For example Figure 7As shown, under X-ray monitoring, the vertebral body bending dilation balloon catheter is inserted through the bending channel and advanced along the preset path to accurately locate the center of the lesion.

[0058] 6. Under X-ray monitoring, balloon 3 is inflated to the rated pressure, forming a cavity within the vertebral body. After expansion, balloon 3 is aspirated and emptied. When withdrawing the catheter, the axial thrust is released, and the internal support wire 41 automatically straightens, restoring the catheter to a straight shape. It is then smoothly and completely withdrawn through the working cannula 5, significantly reducing the risk of withdrawal.

[0059] All the devices (parts whose specific structures are not specified) selected in this application are general standard parts or parts known to those skilled in the art. Their structures and principles can be learned by those skilled in the art through technical manuals or conventional experimental methods.

[0060] In the description of the embodiments of this utility model, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0061] In the description of this utility model, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings and are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0062] In the several embodiments provided in this application, it should be understood that the disclosed systems, apparatuses, and methods can be implemented in other ways. The apparatus embodiments described above are merely illustrative. For example, the division of units is only a logical functional division, and in actual implementation, there may be other division methods. Furthermore, multiple units or components may be combined or integrated into another system, or some features may be ignored or not executed. Additionally, the shown or discussed mutual couplings, direct couplings, or communication connections may be through some communication interfaces; indirect couplings or communication connections between devices or units may be electrical, mechanical, or other forms.

[0063] The units described as separate components may or may not be physically separate. The components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple network units. Some or all of the units can be selected to achieve the purpose of this embodiment according to actual needs.

[0064] In addition, in the various embodiments of this utility model, each functional unit can be integrated into one processing unit, or each unit can exist physically separately, or two or more units can be integrated into one unit.

[0065] Based on the above-described preferred embodiments of this utility model, and through the foregoing description, those skilled in the art can make various changes and modifications without departing from the technical concept of this utility model. The technical scope of this utility model is not limited to the contents of the specification, but must be determined according to the scope of the claims.

Claims

1. A vertebral body curved dilation balloon catheter, characterized by, include Outer tube, handle assembly, balloon, and support wire assembly; The support wire assembly is inserted into the outer tube and the balloon. The rear end of the support wire assembly is connected to the handle assembly, and the front end of the support wire is heat-fused to the front end of the balloon. The support wire assembly includes a support wire, a spring tube, and a guide head. The front end of the support wire is provided with a variable diameter section, which is located inside the balloon. The spring tube is sleeved on the variable diameter section. The rear end of the spring tube is welded and fixed to the large diameter end of the variable diameter section. The front end of the spring tube is welded and fixed to the guide head and the small diameter end of the variable diameter section.

2. The vertebral body bending dilation balloon catheter according to claim 1, characterized in that, The support wire and the balloon are joined by hot-melt welding to form a welded block, and the front end face of the welded block forms a guide slope.

3. The vertebral body bending dilation balloon catheter according to claim 1, characterized in that, The major diameter of the variable diameter section is 1-1.5 mm, and the minor diameter is 0.2-0.4 mm; The length of the variable diameter section is 10-25mm.

4. The vertebral body bending dilation balloon catheter according to claim 1, characterized in that, The handle assembly includes a three-way handle and a white nut. The white nut is threadedly connected to the rear end of the three-way handle, and the rear end of the support wire is fixed to the white nut by adhesive.

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